Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04855565




Registration number
NCT04855565
Ethics application status
Date submitted
16/04/2021
Date registered
22/04/2021
Date last updated
30/08/2021

Titles & IDs
Public title
ALY688-SR in Generally Healthy Overweight or Obese Adults
Scientific title
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults
Secondary ID [1] 0 0
ALY688-SR-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALY688-SR

Active Comparator: ALY688-SR - single dose subcutaneous injection

Placebo Comparator: Matching placebo for ALY688-SR - single dose subcutaneous injection


Treatment: Drugs: ALY688-SR
single dose subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change between pre- and post-intervention safety and tolerability assessments
Timepoint [1] 0 0
baseline, pre-intervention through study completion at 16 days

Eligibility
Key inclusion criteria
- Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled
hypercholesterolemia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2021
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allysta Pharmaceutical
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
INC Research Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
First in human study of ALY688-SR administered as a subcutaneous injection
Trial website
https://clinicaltrials.gov/ct2/show/NCT04855565
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Snyder, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04855565